Italy Deployed Eyenuk’s EyeArt AI Eye Screening System for First National Retinal and Diabetic Maculopathy Prevention and Diagnosis Campaign

EyeArt System Identified Referable Diabetic Retinopathy in 214 Patients Never Diagnosed Before

Eyenuk Inc., a global artificial intelligence (AI) medical technology and services company and the leader in real-world applications for AI Eye Screening™, announced today that the EyeArt® AI Eye Screening System was deployed successfully for Italy’s first national prevention and diagnosis campaign for retinal and diabetic maculopathy. A total of 2,200 patients were screened at 30 centers across Italy, with more than half chosen for EyeArt AI Eye Screening. The Month of Prevention of Diabetic Retinopathy and Maculopathy was sponsored by the Italian Ministry of Health, the city of Milan and the Italian Ophthalmology Society in collaboration with the Ambrosian Ophthalmic Center (CAMO), San Raffaele Hospital and Eyenuk.

In Italy, an estimated 3.2 million patients have diabetes. As many as 25% are estimated to be affected by diabetic retinopathy (DR),1 the main cause of vision impairment and blindness among working-age adults. DR occurs when high blood sugar levels lead to damage of the blood vessels in the light-sensitive tissue at the back of the eye, called the retina. Annual eye screening is recommended for people with diabetes since DR can progress silently without any perceptible symptoms or vision deterioration.

The EyeArt AI System uses artificial intelligence algorithms to autonomously analyze images of the eye taken with a retinal camera. Of the patients who underwent EyeArt AI Eye Screening, 214 patients were identified as having referable DR never diagnosed before; all were referred to eye care specialists to save their vision. The EyeArt AI System is the most extensively validated AI technology for autonomous detection of DR to date, tested in real-world settings on more than a half-million patient visits with more than 2 million images collected globally. In a prospective, pivotal clinical trial on more than 900 patients, the EyeArt System was shown to have 95.5% sensitivity and 86% specificity for detecting referable DR.

"Using the EyeArt AI System for our screening campaign was an extraordinary success. Nearly 17% of the patients screened had never received a complete diabetic eye exam, and another 8% hadn’t been screened in more than four years," says Dr. Lucio Buratto, scientific director of CAMO. “With the EyeArt AI System, we were able to examine thousands of patients in a fraction of the time that it would have otherwise taken. We can conclude that a prompt diagnosis and proper treatment could reduce 50-70% of the cases that show a severe visual impairment due to diabetes and DR. What’s more, early detection means the cost of health and social care will be significantly lower. We look forward to using the EyeArt AI System in future campaigns and in our clinics.”

The EyeArt AI System allows diabetes care providers to quickly and accurately identify patients with referable DR, without needing eye care expertise on-site, so at-risk patients can be immediately referred to an ophthalmologist for further evaluation and vision-saving treatment. The EyeArt AI System removes the biggest obstacles to annual DR screening and diagnosis: timely access to screening and patient compliance.

“We are proud to be part of the first national screening campaign for diabetic retinopathy and maculopathy in Italy,” says Kaushal Solanki, CEO of Eyenuk. “Giving eye care providers the power to quickly screen thousands of people is gratifying, and we look forward to participating in similar initiatives worldwide.”

Eyenuk will showcase its EyeArt AI Eye Screening System at the European Association for the Study of Diabetes (EASD) annual meeting (Booth #D.02) Sept. 16-20, 2019, in Barcelona, Spain.

The EyeArt AI Eye Screening System provides fully automated DR screening, including retinal imaging, DR grading on international standards and reporting on-site, in a single office visit during a diabetic patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the DR screening results are available in a PDF report in less than 60 seconds.

About Eyenuk Inc.

Eyenuk Inc. is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screening for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk’s first product, the EyeArt AI Eye Screening System, is the most extensively validated AI technology for autonomous detection of DR. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk and Alzheimer’s disease. Find Eyenuk online on its website, Twitter, Facebook, and LinkedIn.

The EyeArt System has CE marking and has been cleared for sales as a Class IIa medical device by the European Union and as a Class 2 medical device by Health Canada. In the U.S., the EyeArt System is limited to investigational use only.